MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-08-07 for PLATELIA ASPERGILLUS AG 62794 manufactured by Bio-rad Laboratories, Inc..
[3708120]
Bio-rad laboratories technical support received a call on (b)(4) 2013 from (b)(4) lab partners to request assistance in determining the cause of low ods of the cut-off controls in the platelia aspergilus ag assay. Specifically, assays were reported to have failed the qc criteria for the cut-off controls over the last two months since the laboratory moved locations. The cut-off control ods for some assay runs were being adjusted by the customer in order to meet qc criteria requirements and to facilitate reporting of pt results from these otherwise invalid assay runs. Pt results obtained with these runs were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3022521-2013-00001 |
| MDR Report Key | 3284288 |
| Report Source | 07 |
| Date Received | 2013-08-07 |
| Date of Report | 2013-08-05 |
| Date of Event | 2013-07-10 |
| Date Mfgr Received | 2013-07-10 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2013-11-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SCOTT DENNIS |
| Manufacturer Street | 6565 185TH AVE., N.E. |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4254981741 |
| Manufacturer G1 | BIO-RAD LABORATORIES |
| Manufacturer Street | 3, BOULEVARD RAYMOND POINCARE |
| Manufacturer City | MARNES-LA-COQUETTE 92430 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 92430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLATELIA ASPERGILLUS AG |
| Generic Name | IVD, EIA |
| Product Code | NOM |
| Date Received | 2013-08-07 |
| Catalog Number | 62794 |
| Lot Number | 2J0118 |
| Device Expiration Date | 2013-09-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES, INC. |
| Manufacturer Address | MARNES-LA-COQUETTE 92430 FR 92430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-07 |